AGGRASTAT 0.25mg/ml Infusion/Concentrate for

What is AGGRASTAT 0.25mg/ml

AGGRASTAT is the brand name for **tirofiban hydrochloride monohydrate**, a potent intravenous antiplatelet medication. It is formulated as a **concentrate for infusion**, typically available in 50 ml vials containing 0.25 mg/ml of tirofiban.

• Drug class: Glycoprotein IIb/IIIa receptor antagonist
• Mechanism: Inhibits the final common pathway of platelet aggregation by blocking fibrinogen binding to the GP IIb/IIIa receptor on platelets
• Indications:
  • Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction – NSTEMI)
  • Pre- and post-percutaneous coronary intervention (PCI), to prevent thrombotic events
• Formulation: Clear, sterile, isosmotic concentrate for IV infusion after dilution
• Regulatory status: FDA-approved (first approved in 2000), available generically since 2023 :contentReference[oaicite:1]{index=1}

This intravenous agent is used exclusively under hospital care, often alongside heparin, aspirin, and other antithrombotics, to rapidly reduce the risk of cardiovascular events in high-risk patients :contentReference[oaicite:2]{index=2}.

How to use AGGRASTAT 0.25mg/ml

Administration of AGGRASTAT must be performed by trained medical personnel in a hospital or cath lab setting. Precise dosing, dilution, and monitoring are critical.

• Route: Intravenous only
• Preparation: Must be inspected for clarity and diluted appropriately for infusion; do not shake vigorously :contentReference[oaicite:3]{index=3}.
• Loading dose: 25 µg/kg IV bolus administered over 3–5 minutes
• Maintenance infusion:
  • 0.15 µg/kg/min for up to 18 hours in patients with CrCl >60 ml/min
  • 0.075 µg/kg/min for up to 18 hours in patients with CrCl ≤ 60 ml/min :contentReference[oaicite:4]{index=4}
• Co‑administration: Often given with heparin, aspirin, clopidogrel or bivalirudin. Compatible with multiple IV drugs but not diazepam :contentReference[oaicite:5]{index=5}.
• Monitoring:
  • Continuous cardiac and vascular access monitoring
  • Platelet count baseline, 6 h post‑start, and daily
  • Hemoglobin, hematocrit, renal function regularly
• Adjustments: Dose reduction by 50% in renal impairment (CrCl ≤60 ml/min) :contentReference[oaicite:6]{index=6}.

Preparation must be performed under aseptic conditions, discarding any unused portion in compliance with hospital guidelines.

Mode of Action AGGRASTAT 0.25mg/ml

AGGRASTAT (tirofiban) is a small, non‑peptide, reversible inhibitor of the platelet GP IIb/IIIa receptor—fundamental in final platelet aggregation.

• Target: GP IIb/IIIa integrin receptor on activated platelets
• Effect: Blocks fibrinogen and von Willebrand factor binding, preventing cross‑linking of platelets :contentReference[oaicite:7]{index=7}
• Onset of action: >90% inhibition of platelet aggregation within 10 minutes after bolus dosing :contentReference[oaicite:8]{index=8}
• Duration: Platelet function returns toward baseline within 4–8 hours after stopping infusion :contentReference[oaicite:9]{index=9}
• Therapeutic benefit: Reduces risk of death, myocardial infarction, or refractory ischemia in patients with NSTE‑ACS and in those undergoing PCI :contentReference[oaicite:10]{index=10}

AGGRASTAT 0.25mg/ml Interactions AGGRASTAT 0.25mg/ml

AGGRASTAT significantly increases bleeding risk when used with other antithrombotic agents. Concomitant use requires caution and often dose adjustment.

• Anticoagulants:
  • Heparin, LMWH (enoxaparin), bivalirudin – additive bleeding risk; often co‑administered but intensifies monitoring :contentReference[oaicite:11]{index=11}
  • DOACs (apixaban, rivaroxaban) – increased risk; avoid or adjust :contentReference[oaicite:12]{index=12}
  • Warfarin – use with caution; may enhance bleeding
• Other GP IIb/IIIa inhibitors: eptifibatide, abciximab – avoid due to cumulative effect :contentReference[oaicite:13]{index=13}
• Thrombolytics: Clot‑busting drugs intensify bleeding risk; used with extreme caution
• NSAIDs and aspirin: Increase bleeding risk; low-dose aspirin often co-administered :contentReference[oaicite:14]{index=14}
• CYP inducers/inhibitors or herbal supplements: Some (e.g. garlic, ginkgo, vitamin A) may potentiate bleeding :contentReference[oaicite:15]{index=15}
• Abrocitinib: Contraindicated due to synergistic anticoagulant effects :contentReference[oaicite:16]{index=16}

Always review all concomitant therapies and adjust protocols based on bleeding and renal function assessments.

Dosage of AGGRASTAT 0.25mg/ml

Dosage is weight-based and adjusted for renal impairment. Total therapy duration should not exceed 18 hours.

• Loading (bolus): 25 µg/kg IV administered over 3–5 minutes
• Maintenance infusion:
  • Normal renal function (CrCl > 60 ml/min): 0.15 µg/kg/min for up to 18 hours
  • Renal impairment (CrCl ≤ 60 ml/min): 0.075 µg/kg/min for up to 18 hours :contentReference[oaicite:17]{index=17}
• Duration: 18–24 hours
• Special considerations:
  • Weight and renal function calculate infusion rate (mL/hr) based on drug concentration (e.g., 50 µg/ml)
  • Limit total infusion length to care plan; beyond 24 hours usually not recommended
• Monitoring:
  • Frequent platelet counts – baseline, 6 h post-start, daily
  • Check renal function and adjust as needed

Possible side effects of AGGRASTAT 0.25mg/ml

Tirofiban’s side effects are primarily related to bleeding, but diverse symptoms may occur.

• Common (≥10%):
  • Vascular site bleeding or bruising
  • Nausea, headache, hypotension
  • Minor hematoma, gum bleeding :contentReference[oaicite:18]{index=18}
• Serious but less common:
  • Major bleeding (GI, intracranial, retroperitoneal, pulmonary) :contentReference[oaicite:19]{index=19}
  • Severe thrombocytopenia (< 90,000/mm³) reported in ~1–1.5%, often reversible :contentReference[oaicite:20]{index=20}
  • Allergic reactions: rash, anaphylaxis, angioedema :contentReference[oaicite:21]{index=21}
• Other possible effects: leg/back pain, chills, fever, dizziness, bradycardia :contentReference[oaicite:22]{index=22}

Monitoring is key: Track platelet counts, hemoglobin, signs of bleeding, vital signs, especially during infusion and up to 8 hours afterward when hemostatic function returns toward baseline.

AGGRASTAT 0.25mg/ml Contraindications AGGRASTAT 0.25mg/ml

Certain conditions pose high bleeding risk or pharmacological unsuitability for AGGRASTAT use:

• Absolute contraindications:
  • Active internal bleeding or bleeding diathesis
  • History of hemorrhagic stroke or CNS vascular lesions
  • Major surgery, trauma, or GI bleeding within last 30 days
  • Severe hypertension uncontrolled
  • Thrombocytopenia (< 100,000/mm³ or history of tirofiban-induced)
  • Known hypersensitivity to tirofiban or excipients :contentReference[oaicite:23]{index=23}
• Relative contraindications:
  • Recent lumbar puncture or neuraxial anesthesia
  • PUD with bleeding history
  • Severe renal or hepatic impairment
  • Concomitant potent anticoagulants or antiplatelets outside supervised settings :contentReference[oaicite:24]{index=24}
• Cautions: Elderly, low body weight, high bleeding risk, women, renal impairment require careful balance and intensified monitoring :contentReference[oaicite:25]{index=25}

Storage of AGGRASTAT 0.25mg/ml

• Temperature: Store vials at 20–25 °C (68–77 °F); excursions allowed 15–30 °C :contentReference[oaicite:26]{index=26}
• Do not freeze: Freezing may damage product integrity :contentReference[oaicite:27]{index=27}
• Light protection: Keep in outer carton to avoid direct light exposure
• Inspection: Check solution is clear and particulate-free before use :contentReference[oaicite:28]{index=28}
• After dilution:
  • Use within 24 hours if stored at controlled room temperature (20–25 °C) under aseptic technique :contentReference[oaicite:29]{index=29}
• Labeling: Include patient ID, concentration, start and expiry time
• Disposal: Follow hospital biomedical regulations for medication and sharps waste :contentReference[oaicite:30]{index=30}